FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LONG LIFE PADTM
K Number: K120516
·
Decision May 17, 2012
Classifications
1
FEI Numbers
243
Registration Numbers
243
Same Product Code
436
Applicant Total
68
Review Days
86
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- LONG LIFE PADTM
- K Number
- K120516
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1320
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Omron Healthcare, Inc.
- Date Received
- February 21, 2012
- Decision Date
- May 17, 2012
- Product Code
- GXY
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GXY | Electrode, Cutaneous | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GXY), ordered by most recent decision date.
BioWave BioWraps
FDA 510(k)
FDA Class 2
·Neurology
Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode)
FDA 510(k)
FDA Class 2
·Neurology
MR Conditional Cup Electrodes
FDA 510(k)
FDA Class 2
·Neurology
Tutamen Self Adhesive Electrodes
FDA 510(k)
FDA Class 2
·Neurology
myosmart. (13E522); myosmart.cuff (757M20-2); connectgrip. (560X27-1); myosmart trial kit (642V64=T)
FDA 510(k)
FDA Class 2
·Neurology
Ceribell Brain Monitor Headband
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by Omron Healthcare, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| DEN230076 | Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)); Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP5460 (HEM-7372T1-AZAZ)) | Oct 8, 2024 | Unknown |
| K202228 | Omron Model BP7900 Blood Pressure Monitor + EKG | Apr 1, 2021 | Substantially Equivalent |
| K183215 | Focus TENS Therapy, Model PM710-M/-L | Sep 7, 2019 | Substantially Equivalent |
| K190693 | HEM-6410T-ZL Wrist Blood Pressure Monitor | Apr 17, 2019 | Substantially Equivalent |
| K182579 | Omron Model BP7900 Blood Pressure Monitor + EKG | Mar 14, 2019 | Substantially Equivalent |
| K182120 | Maxpower Relief | Jan 10, 2019 | Substantially Equivalent |
| K181992 | Heat Pain Pro | Nov 9, 2018 | Substantially Equivalent |
| K182481 | HEM-6410T-ZM Wrist Blood Pressure Monitor | Nov 9, 2018 | Substantially Equivalent |
| K182166 | Wrist Blood Pressure Monitor Model BP4350 | Nov 8, 2018 | Substantially Equivalent |
| K182127 | Wrist Blood Pressure Monitor Model BP6100 | Nov 2, 2018 | Substantially Equivalent |